Aseptic and Qualification Project Lead

Job Description Summary

The Aseptic and Qualification Project Lead is accountable for leading and coordinating all technical training initiatives across the operations organization with a key specialized focus on production qualification projects. As a vital member of the team, the Lead will oversee the development and implementation of training programs, facilitate the creation of high-quality training materials, procedures, protocols, records, actively support the training plan by engaging with various stakeholders within a classroom for aseptic training environments and new technologies. With a focus on optimizing employee skillsets and knowledge, Aseptic and Qualification Project Lead will play a crucial role in elevating the organization's technical capabilities and fostering a culture of continuous learning and growth.

 

Job Description

Major Accountabilities

• Develop and implement comprehensive technical training programs and curricula to address the learning needs of employees.
• Site point of contact for planning, orchestrating, executing, and closing all activities linked to production operator qualifications
• Primary liaison between the project team and production operations to ensure all qualification/tech transfer initiatives are successful implemented by seamlessly integrating the training and process learning into the existing training program and applicable personnel
• Support in defining and planning agendas, delivering content and lead preparation for key site management engagements and governance meetings for assigned projects
• Establish Project Change Management & manage changes successfully throughout a complex multifunctional organization
• Manage and design engaging and effective training materials, presentations, and hands-on activities to facilitate learning in a classroom and more importantly aseptic production environment.
• Coordinate and conduct technical training sessions for employees at all levels.
• Collaborate with subject matter experts and stakeholders to identify training requirements and ensure training content aligns with business objectives.
• Evaluate and assess the effectiveness of training programs through feedback, surveys, and performance metrics.
• Continuously update and improve training materials and methodologies-based shop floor best practices and industry trends.
• Monitor and track the progress of trainees, providing additional support or resources as needed to ensure successful outcomes.
• Establish and maintain training documentation, including manuals, guides, operator training records and online resources for easy access and reference.
• Act as a mentor and coach to employees, assisting them in their technical development and career growth.
• Liaise with other departments and teams to address cross-functional training needs and ensure a cohesive learning experience.
• Collaborate with external training providers, if necessary, to source specialized technical training programs.
• Stay abreast of advancements in technology and industry standards to incorporate relevant updates into training content.
• Champion a culture of continuous learning and professional development throughout the organization.
• Provide regular progress reports and updates to management and stakeholders on the effectiveness and impact of technical training initiatives development.

Key Requirements:

• Bachelor’s degree in education, science or related field or equivalent experience
• 4 years’ relevant experience required with aseptic pharmaceutical manufacturing
• Direct experience working in a cGMP and aseptic environment is highly desired.
• Prior experience or training in radiochemistry or radio pharmacy desired
• Strong leadership, communication and analytical/problem solving skills
• Demonstrated history of working collaboratively across functions and sites.
• Knowledge and understanding of cGMP requirements and the application of continuous improvement in a regulated environment.
• 5-10% travel

 

 

EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. 

 

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [email protected] or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

 

Salary Range

$77,000.00 - $143,000.00

 

Skills Desired

Change Control, Chemical Engineering, Continual Improvement Process, Efficiency, Employment Discrimination, Flexibility, General Hse Knowledge, Good Documentation Practice, Knowledge Of Capa, Knowledge Of Gmp, Lean Manufacturing, Manufacturing Process, Manufacturing Production, Physics, Process Control, Production Line, Productivity, Risk Management, Root Cause Analysis (RCA), Scheduler, Technology Transfer, Well-Being